Company: Zimmer Biomet, Inc.
Date of Enforcement Report 3/29/2017
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Recall Number Z-1495-2017
Digital templates were created with the incorrect files.
Zimmer Biomet, Inc., Warsaw, IN on 2/14/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally